Principal Scientist in Steriles Process Engineering and Analytics

GSK•Upper Providence, PA

1d•Hybrid

About The Position

This role is within the Technology Development and Process Engineering team, focusing on designing innovative ways to use Engineering, Process Analytics Technologies, Automation and Modelling to develop medicines for patients. The Principal Investigator will utilize knowledge and experience of drug product unit operations, Process Engineering, and modelling to assess, develop, and implement new manufacturing platforms. This includes supporting scale-up, technology transfer, and manufacture of Sterile drug products (Biopharms, small molecule suspensions, ADCs, oligonucleotides, Vaccines) through to commercialization. The role involves close collaboration with automation experts and data scientists to enable efficiencies during drug product development. This multi-disciplinary role offers opportunities for career development with mentorship from experienced professionals.

Requirements

Ph.D. in Chemical Engineering, Biochemical Engineering, or related field
Experience in protein formulation and/or drug product development and technology transfer
OR MS degree with 10+ years of related experience
OR BS degree with 13+ years of related experience

Nice To Haves

Experience in or exposure in an academic context to Sterile drug product (e.g., Biopharma, suspensions, ADCs, oligonucleotides, or Vaccines) development drug product process development, characterization, scale-up and technology transfer modelling, and, to deliver processes that are well understood
Experience in the application of state-of-the-art laboratory equipment, equipment automation, data automation, PAT tools and modelling software.
Experience in evaluating, developing, and qualifying manufacturing equipment.

Responsibilities

Work as part of a multi-disciplinary development team, liaising with Formulators, Modelers, Process Analytical Technology (PAT) scientists, automation experts, data scientists, device engineers, and engineers from R&D Pilot Plants and Global Supply Chain manufacturing sites, to understand unit operations in drug product manufacture and scale up these processes.
Lead technical reviews on projects and contribute to the technical transfer of processes, including leading technical transfer activities, preparing functional project plans, and ensuring timely execution.
Contribute to CMC and MPD team planning and objective setting, agreeing priorities and coordinating Process Engineering and Analytics activities.
Use experimental data and models to solve complex process development problems.
Advance scientific understanding and improve current ways of working by championing new automation and PAT tools and models, participating in technical focus networks, external collaborations with academics, and applying current literature knowledge.
Minimize DOE’s for scalability assessments and API consumption by driving smart decisions.
Be technically persuasive within GSK and externally with the academic community.
Ensure appropriate scientific review is in place throughout development and prior to key Project milestones.
Prepare and deliver Process Engineering and Analytics-relevant sections of technical and governance presentations.
Identify and escalate Process Engineering and Analytics-related risks.
Author sections of regulatory documents relevant to Process Engineering platforms (IND / IMPD submissions, marketing applications, CMC briefing etc.).
Lead platform development workstreams to assess, develop, and implement new manufacturing platforms, automate development work packages, and establish control strategies.
Be accountable for platform robustness across the portfolio.
Become an expert in specific unit operations within the sterile portfolio.
Work closely with automation team and data scientists to automate work packages and standardize data generation and analysis.
Utilize effective planning to deliver work efficiently, enabling automation or outsourcing where required.
Deliver work in a precise and timely manner, adhering to safety and quality expectations.
Comply with Quality, Safety, and GSK policies and procedures, and ensure GSK intellectual property is protected.